Document:USA 45 CFR Part 46 09-Apr-2025: Difference between revisions
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Revision as of 19:36, 27 June 2026
| Document information | |
|---|---|
| Reference | USA 45 CFR Part 46 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 45 CFR Part 46 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 45—Public Welfare
Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b) | G | § 46.102
(b) || EN || (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the ... | ||
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.104 | G | § 46.104 | EN | § 46.104 Exempt research. […] |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112 | G | § 46.107 - § 46.112 | EN | § 46.107 IRB membership. […] § 46.108 IRB functions and operations. […] § 46.109 IRB review of research. […] § 46.110 Expedited review procedures for certain kinds of research involving no more than ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.115 | G | § 46.115 | EN | § 46.115 IRB records. […] |
| Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart E | G | Subpart E | EN | Subpart E—Registration of Institutional Review Boards […] § 46.501 What IRBs must be registered? Each IRB that is designated by an institution under an assurance of compliance approved for ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.124 | G | § 46.124 | EN | § 46.124 Conditions. With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1) | G | § 46.102
(e) (1) || EN || (e) (1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or ... | ||
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.116 | G | § 46.116 | EN | § 46.116 General requirements for informed consent. (a) General. General requirements for informed consent, whether written or oral, […] (b) Basic elements of informed consent […] (c) Additional ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.117 | G | § 46.117 | EN | § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B | G | Subpart B | EN | Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research […] § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C | G | Subpart C | EN | Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects […] § 46.303 Definitions. […] (c) Prisoner means any individual involuntarily ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D | G | Subpart D | EN | Subpart D—Additional Protections for Children Involved as Subjects in Research […] § 46.402 Definitions. The definitions in § 46.102 of the pre-2018 Requirements and the 2018 Requirements, as ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) | G | § 46.102
(m) || EN || (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format. | ||
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.113 | G | § 46.113 | EN | § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's ... |
| Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.123 | G | § 46.123 | EN | § 46.123 Early termination of research support: Evaluation of applications and proposals. (a) The department or agency head may require that Federal department or agency support for any project be ... |
